FDA WARNING_LETTER - United Contact Lens - June 15, 2011

On September 9, 2011, the FDA issued a Warning Letter to United Contact Lens, Inc., following an inspection on June 14-15, 2011, which found the firm manufactures soft contact lenses. The devices were deemed misbranded under section 502(o) of the Act because the establishment was not duly registered under section 510 and the devices were not listed as required by section 510(j). The firm failed to fulfill annual registration and listing requirements for fiscal years 2009, 2010, and 2011, despite previous promises and a February 28, 2011, notification.

Additionally, the inspection revealed quality system deficiencies under 21 CFR Part 820 (CGMP requirements). Violations included failure to establish and maintain acceptance procedures for in-process product (21 CFR 820.80(c)), specifically not documenting ten contact lens rejections in the Dry Power Thickness Inspection Reject Log. The firm also failed to establish and maintain procedures for routine equipment calibration and documentation (21 CFR 820.72(a)), as evidenced by undocumented calibration results for the curing oven. The firm's responses to these violations were deemed inadequate due to a lack of supporting documentation for investigations, training, and revised procedures.

United Contact Lens was required to respond in writing within fifteen business days